[Federal Register Volume 69, Number 201 (Tuesday, October 19, 2004)]
[Notices]
[Pages 61466-61467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-2710]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-075-1]


Monsanto Co. and KWS SAAT AG; Availability of Petition and 
Environmental Assessment for Determination of Nonregulated Status for 
Sugar Beet Genetically Engineered for Tolerance to the Herbicide 
Glyphosate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from Monsanto Company and 
KWS SAAT AG seeking a determination of nonregulated status for sugar 
beet designated as event H7-1, which has been genetically engineered 
for tolerance to the herbicide glyphosate. The petition has been 
submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
In accordance with those regulations, we are soliciting public comments 
on whether this sugar beet presents a plant pest risk. We are also 
making available for public comment an environmental assessment for the 
proposed determination of nonregulated status.

DATES: We will consider all comments we receive on or before December 
20, 2004.

ADDRESSES: You may submit comments by any of the following methods:
    Postal Mail/Commercial Delivery: Please send four copies of your 
comment (an original and three copies) to Docket No. 04-075-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 04-075-1.
    E-mail: Address your comment to [email protected]. Your 
comment must be contained in the body of your message; do not send 
attached files. Please include your name and address in your message 
and ``Docket No. 04-075-1'' on the subject line.
    Agency Web site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through 
the APHIS Web site.
    Federal eRulemaking Portal: Go to http://www.regulations.gov and 
follow the instructions for locating this docket and submitting 
comments.
    Reading Room: You may read the petition, the environmental 
assessment, and any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    Other Information: You may view APHIS documents published in the 
Federal Register and related information, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Mr. John Cordts, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5531. To obtain copies of the petition or the 
environmental assessment (EA), contact Ms. Terry Hampton at (301) 734-
5715; e-mail: [email protected]. The petition and the EA 
are also available on the Internet at: http://www.aphis.usda.gov/brs/aphisdocs/03_32301p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_32301p_ea.pdf.

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, 
``Introduction of Organisms and Products Altered or Produced Through 
Genetic Engineering Which Are Plant Pests or Which There Is Reason to 
Believe Are Plant Pests,'' regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products altered or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests. Such genetically engineered organisms and 
products are considered ``regulated articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a

[[Page 61467]]

determination that an article should not be regulated under 7 CFR part 
340. Paragraphs (b) and (c) of Sec.  340.6 describe the form that a 
petition for a determination of nonregulated status must take and the 
information that must be included in the petition.
    On November 19, 2003, APHIS received a petition (APHIS Petition 
Number 03-323-01p) from Monsanto Company of St. Louis, MO, and KWS SAAT 
AG of Einbeck, Germany (Monsanto/KWS), requesting a determination of 
nonregulated status under 7 CFR part 340 for sugar beet (Beta vulgaris 
ssp. vulgaris) designated as event H7-1, which has been genetically 
engineered for tolerance to the herbicide glyphosate. The Monsanto/KWS 
petition states that the subject sugar beet should not be regulated by 
APHIS because it does not present a plant pest risk. As described in 
the petition, sugar beet event H7-1 has been genetically engineered to 
express a 5-enolpyruvyshikimate-3-phosphate synthase protein from 
Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to 
the herbicide glyphosate. Expression of the added genes is controlled 
in part by the 35S promoter derived from the plant pathogen figwort 
mosaic virus. The Agrobacterium tumefaciens transformation method was 
used to transfer the added genes into the KWS proprietary sugar beet 
line 3S0057.
    Sugar beet event H7-1 has been considered a regulated article under 
the regulations in 7 CFR part 340 because it contains gene sequences 
from plant pathogens. In the process of reviewing the notifications for 
field trials of the subject sugar beet, APHIS determined that the 
vectors and other elements were disarmed and that the trials, which 
were conducted under conditions of reproductive and physical 
confinement or isolation, would not present a risk of plant pest 
introduction or dissemination.
    In Sec.  403 of the Plant Protection Act (7 U.S.C. 7701-7772), 
plant pest is defined as any living stage of any of the following that 
can directly or indirectly injure, cause damage to, or cause disease in 
any plant or plant product: A protozoan, a nonhuman animal, a parasitic 
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or 
other pathogen, or any article similar to or allied with any of the 
foregoing. APHIS views this definition very broadly. The definition 
covers direct or indirect injury, disease, or damage not just to 
agricultural crops, but also to plants in general, for example, native 
species, as well as to organisms that may be beneficial to plants, for 
example, honeybees, rhizobia, etc.
    The U.S. Environmental Protection Agency (EPA) is responsible for 
the regulation of pesticides under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA 
requires that all pesticides, including herbicides, be registered prior 
to distribution or sale, unless exempt by EPA regulation. In cases in 
which genetically modified plants allow for a new use of a pesticide or 
involve a different use pattern for the pesticide, EPA must approve the 
new or different use. Accordingly, EPA has granted a registration for 
the use of glyphosate on glyphosate-tolerant sugar beet.
    When the use of the pesticide on the genetically modified plant 
would result in an increase in the residues in a food or feed crop for 
which the pesticide is currently registered, or in new residues in a 
crop for which the pesticide is not currently registered, establishment 
of a new tolerance or a revision of the existing tolerance would be 
required. Residue tolerances for pesticides are established by EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 
U.S.C. 301 et seq.), and the Food and Drug Administration (FDA) 
enforces tolerances set by EPA under the FFDCA. EPA has determined that 
the existing residue tolerance for glyphosate-tolerant sugar beet is 
sufficient to support future use of glyphosate on event H7-1.
    FDA published a statement of policy on foods derived from new plant 
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005). 
The FDA statement of policy includes a discussion of FDA's authority 
for ensuring food safety under the FFDCA, and provides guidance to 
industry on the scientific considerations associated with the 
development of foods derived from new plant varieties, including those 
plants developed through the techniques of genetic engineering. 
Monsanto/KWS has begun consultation with FDA on the subject sugar beet 
event.
    To provide the public with documentation of APHIS' review and 
analysis of the environmental impacts and plant pest risk associated 
with a proposed determination of nonregulated status for the Monsanto/
KWS event H7-1 sugar beet, an environmental assessment (EA) has been 
prepared. The EA was prepared in accordance with (1) The National 
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et 
seq.), (2) regulations of the Council on Environmental Quality for 
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    In accordance with Sec.  340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested persons for a period of 60 days 
from the date of this notice. We are also soliciting written comments 
from interested persons on the EA prepared to examine any environmental 
impacts of the proposed determination for the subject sugar beet event. 
The petition and the EA and any comments received are available for 
public review, and copies of the petition and the EA are available as 
indicated in the FOR FURTHER INFORMATION CONTACT section of this 
notice.
    After the comment period closes, APHIS will review the data 
submitted by the petitioner, all written comments received during the 
comment period, and any other relevant information. After reviewing and 
evaluating the comments on the petition and the EA and other data and 
information, APHIS will furnish a response to the petitioner, either 
approving the petition in whole or in part, or denying the petition. 
APHIS will then publish a notice in the Federal Register announcing the 
regulatory status of the Monsanto/KWS glyphosate-tolerant sugar beet 
event H7-1 and the availability of APHIS' written decision.

    Authority:  7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.

    Done in Washington, DC, this 14th day of October 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E4-2710 Filed 10-18-04; 8:45 am]
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